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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03374436
Other study ID # H17-01747
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date August 30, 2019

Study information

Verified date September 2019
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prolonged sitting has been shown to impair metabolism and vascular function. The overall purpose of this study is to determine if breaking up prolonged (9 hours) of sitting with brief (~20 second) stair climbing exercise "snacks" can improve markers of metabolic control and vascular health in healthy young male participants and in males or females with overweight/obesity who are at risk of insulin resistance. An additional purpose is to determine if saliva insulin can be used as a valid indicator of blood insulin when measured throughout the day in sedentary and active conditions and when diets with different amounts of carbohydrates are consumed.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date August 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Lean Group Inclusion Criteria:

Non-smoking

Lean Group Exclusion Criteria:

Diagnosed with diabetes or prediabetes (fasting blood sugar more than 6.0 mmol/l) or any other chronic condition that may impact glucose or insulin levels.

BMI is over 25 kg/m2 Take medications which may affect glucose and insulin levels Allergic to eggs. Smoker Competitive or serious endurance athlete.

Overweight/Obese Group Inclusion Criteria:

Elevated waist circumference (>102 cm for male and >88 cm for female)

Overweight/Obese Group Exclusion Criteria:

Diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) Take medications which may affect glucose and insulin levels Allergic to eggs. Smoker Competitive or serious endurance athlete.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High-Carbohydrate Sedentary
Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period.
High-Carbohydrate Active
Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period except that once every hour they will ascend three flights of stairs vigorously (stair climbing sprint "snack") for a total of 8 active breaks.
Low-carbohydrate Sedentary
Three low-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period. This condition will provide a condition where the blood glucose and insulin responses are relatively low and stable throughout the day.

Locations

Country Name City State
Canada University of British Columbia Okanagan Kelowna British Columbia

Sponsors (3)

Lead Sponsor Collaborator
University of British Columbia CoreHealth Technologies Inc., Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma insulin area under the curve The plasma insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule. Measured across 9 hours of each intervention day
Secondary Saliva insulin area under the curve The saliva insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule. Measured across 9 hours of each intervention day
Secondary Plasma glucose area under the curve The plasma glucose concentration measured by hexokinase method area under the curve will be measured using the trapezoidal rule. Measured across 9 hours of each intervention day
Secondary Plasma triglyceride area under the curve The plasma triglyceride concentration measured by biochemical assay area under the curve will be measured using the trapezoidal rule. Measured across 9 hours of each intervention day
Secondary Plasma non-esterified fatty acids area under the curve The plasma non-esterified fatty acid concentration measured by biochemical assay area under the curve will be measured using the trapezoidal rule. Measured across 9 hours of each intervention day
Secondary Femoral artery flow-mediated dilation Flow-mediated dilation of femoral artery measured by vascular ultrasound Measured in the morning (time 0 hours) and afternoon (time 8.5 hours) each intervention day
Secondary Cerebrovascular function Cerebrovascular function measured by transcranial doppler ultrasound Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
Secondary Cognitive function Cognitive function measured by Computerized Neurocognitive Assessment Software (CNS) Vital Signs test battery Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
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